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Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study
BACKGROUND: While docetaxel/cisplatin/5‐fluorouracil (DCF) outperforms CF in first‐line gastric adenocarcinoma, toxicity remains an issue. METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m(2), C 35 mg/m², F...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267119/ https://www.ncbi.nlm.nih.gov/pubmed/34057299 http://dx.doi.org/10.1002/cam4.3976 |
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author | Deleporte, Amélie Van den Eynde, Marc Forget, Frédéric Holbrechts, Stéphane Delaunoit, Thierry Houbiers, Ghislain Kalantari, Hassan R. Laurent, Stéphanie Vanderstraeten, Erik De Man, Marc Vergauwe, Philippe Clausse, Marylene Van Der Auwera, Jacques D’Hondt, Lionel Pierre, Pascal Ghillemijn, Bjorn Covas, Angelique Paesmans, Marianne Ameye, Lieveke Awada, Ahmad Sclafani, Francesco Hendlisz, Alain |
author_facet | Deleporte, Amélie Van den Eynde, Marc Forget, Frédéric Holbrechts, Stéphane Delaunoit, Thierry Houbiers, Ghislain Kalantari, Hassan R. Laurent, Stéphanie Vanderstraeten, Erik De Man, Marc Vergauwe, Philippe Clausse, Marylene Van Der Auwera, Jacques D’Hondt, Lionel Pierre, Pascal Ghillemijn, Bjorn Covas, Angelique Paesmans, Marianne Ameye, Lieveke Awada, Ahmad Sclafani, Francesco Hendlisz, Alain |
author_sort | Deleporte, Amélie |
collection | PubMed |
description | BACKGROUND: While docetaxel/cisplatin/5‐fluorouracil (DCF) outperforms CF in first‐line gastric adenocarcinoma, toxicity remains an issue. METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m(2), C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m(2), C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony‐stimulating factor (G‐CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN). RESULTS: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression‐free survival and overall survival were 5.1 (95% CI, 3.2–6.5) and 8.2 months (95% CI, 6.0–14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0–6.9) and 11.9 months (95% CI, 7.4–15.9), respectively, in arm 2. CONCLUSIONS: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G‐CSF. |
format | Online Article Text |
id | pubmed-8267119 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-82671192021-07-13 Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study Deleporte, Amélie Van den Eynde, Marc Forget, Frédéric Holbrechts, Stéphane Delaunoit, Thierry Houbiers, Ghislain Kalantari, Hassan R. Laurent, Stéphanie Vanderstraeten, Erik De Man, Marc Vergauwe, Philippe Clausse, Marylene Van Der Auwera, Jacques D’Hondt, Lionel Pierre, Pascal Ghillemijn, Bjorn Covas, Angelique Paesmans, Marianne Ameye, Lieveke Awada, Ahmad Sclafani, Francesco Hendlisz, Alain Cancer Med Clinical Cancer Research BACKGROUND: While docetaxel/cisplatin/5‐fluorouracil (DCF) outperforms CF in first‐line gastric adenocarcinoma, toxicity remains an issue. METHODS: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m(2), C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m(2), C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony‐stimulating factor (G‐CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN). RESULTS: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression‐free survival and overall survival were 5.1 (95% CI, 3.2–6.5) and 8.2 months (95% CI, 6.0–14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0–6.9) and 11.9 months (95% CI, 7.4–15.9), respectively, in arm 2. CONCLUSIONS: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G‐CSF. John Wiley and Sons Inc. 2021-05-31 /pmc/articles/PMC8267119/ /pubmed/34057299 http://dx.doi.org/10.1002/cam4.3976 Text en © 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Cancer Research Deleporte, Amélie Van den Eynde, Marc Forget, Frédéric Holbrechts, Stéphane Delaunoit, Thierry Houbiers, Ghislain Kalantari, Hassan R. Laurent, Stéphanie Vanderstraeten, Erik De Man, Marc Vergauwe, Philippe Clausse, Marylene Van Der Auwera, Jacques D’Hondt, Lionel Pierre, Pascal Ghillemijn, Bjorn Covas, Angelique Paesmans, Marianne Ameye, Lieveke Awada, Ahmad Sclafani, Francesco Hendlisz, Alain Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title | Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title_full | Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title_fullStr | Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title_full_unstemmed | Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title_short | Fortnightly or fractionated weekly docetaxel–cisplatin–5‐FU as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study |
title_sort | fortnightly or fractionated weekly docetaxel–cisplatin–5‐fu as first‐line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: the randomized phase ii doge study |
topic | Clinical Cancer Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267119/ https://www.ncbi.nlm.nih.gov/pubmed/34057299 http://dx.doi.org/10.1002/cam4.3976 |
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